Analgesic Efficacy of Perineural Dexamethasone During Supraclavicular Block for Hand Surgery

NCT02154048 | Terminated Phase 2 Results

• 1 other identifier: Pro00019301
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine whether the addition of dexamethasone prolongs analgesia when added to long-acting local anesthetic during single-injection supraclavicular block for outpatient hand surgery.

Conditions

Surgery, Hand

Outcome Measures

Primary Outcomes (1)

• Time to First Analgesic Dose

  48 hours

Study Arms (3)

ropivacaine + dexamethasone

ACTIVE COMPARATOR

This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an IV preservative-free dexamethasone 8 mg injection.

Drug: Ropivacaine; Drug: Dexamethasone

ropivacaine + placebo

PLACEBO COMPARATOR

This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an intravenous (IV) normal saline placebo injection.

Drug: Ropivacaine; Other: Placebo

ropivacaine + dexamethasone + placebo

ACTIVE COMPARATOR

This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with both 1:400,000 epinephrine and preservative-free dexamethasone 8mg and an IV normal saline placebo injection.

Drug: Ropivacaine; Drug: Dexamethasone; Other: Placebo

Interventions

Ropivacaine DRUG

Also known as: Naropin

ropivacaine + dexamethasone; ropivacaine + dexamethasone + placebo; ropivacaine + placebo

Dexamethasone DRUG

ropivacaine + dexamethasone; ropivacaine + dexamethasone + placebo

Placebo OTHER

ropivacaine + dexamethasone + placebo; ropivacaine + placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years of age and older
• Patients scheduled for elective outpatient hand surgery with same day discharge at the Duke Ambulatory Surgery Center

You may not qualify if:

• Patients who refuse regional anesthesia
• Patients in whom peripheral nerve block is contraindicated
• Patients unable to sign/understand consent
• Patients with significant language barriers who cannot comply with data collection process
• Patients with known allergies to local anesthetics
• Pregnancy
• Chronic pain patients or patients requiring chronic opioid treatment
• Patients with a history of diabetes
• Patients with contraindication to steroid administration (allergy, chronic steroid use)

Sponsors & Collaborators

• Duke University: lead

MeSH Terms

Interventions

Ropivacaine; Dexamethasone

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Steve Melton, MD
• Organization: Duke University

steve.melton@duke.edu

919.668.2047

Study Officials

• Stephen Melton, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2014
• First Posted: June 3, 2014
• Study Start: April 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: September 11, 2014
• Results First Posted: September 11, 2014

Record last verified: 2014-09